FDA.reportPublic FDA data

STALIF MIDLINE

Primary DI
00815101029337
Brand
STALIF MIDLINE
Company
Centinel Spine, LLC
Model
STM6030R
Published
2017-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141942000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141942000MIDLINE II TICentinel Spine, Inc.2014-11-07OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815101029337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815101029337008151010293378151010293370815101029337

GMDN Terms#

Term, Definition table
TermDefinition
Metal-polymer composite spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of a non-bioabsorbable synthetic polymer with a metallic coating that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
949024850
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843193102447Prodisc C Instrument03.820.117S2026-09-25
00843193102454Prodisc C, SK, Vivo, Nova Instrument03.820.161S2026-09-25
00843193102461Prodisc C Instrument03.820.153S2026-09-25
00843193102478Prodisc C Instrument03.820.163S2026-09-25
00843193102485Prodisc C Instrument03.820.157S2026-09-25
00843193102492Prodisc C Instrument03.820.167S2026-09-25
00843193102508Prodisc C Instrument03.820.159S2026-09-25
00843193102515Prodisc C Instrument03.820.169S2026-09-25
00843193112699Prodisc C Instrument03.820.1362026-09-25
00843193112705Prodisc C Instrument03.820.1372026-09-25
00843193115300Prodisc C Instrument03.820.130S2026-09-25
00843193115317Prodisc C Instrument03.820.131S2026-09-25
00843193115324Prodisc C Instrument03.820.132S2026-09-25
00843193115331Prodisc C Instrument03.820.133S2026-09-25
00843193115348Prodisc C Instrument03.820.134S2026-09-25
00843193115355Prodisc C Instrument03.820.135S2026-09-25
00843193115362Prodisc C Instrument03.820.140S2026-09-25
00843193115379Prodisc C Instrument03.820.141S2026-09-25
00843193115386Prodisc C Instrument03.820.142S2026-09-25
00843193115706Prodisc C InstrumentIN1545S2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606187565Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187572Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187589Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187596Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187602Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187619Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187633Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.OVD2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCOVD2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCOVD2019-10-31
10888857218772CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
07613153046196AVS PLStryker CorporationOVD2015-09-14
07613153046202AVS PLStryker CorporationOVD2015-09-14
07613153046219AVS PLStryker CorporationOVD2015-09-14
07613153046226AVS PLStryker CorporationOVD2015-09-14
07613153046233AVS PLStryker CorporationOVD2015-09-14
07613153046288AVS PLStryker CorporationOVD2015-09-14
07613153046295AVS PLStryker CorporationOVD2015-09-14
07613153046301AVS PLStryker CorporationOVD2015-09-14
07613153046318AVS PLStryker CorporationOVD2015-09-14
07613153046325AVS PLStryker CorporationOVD2015-09-14
07613153046332AVS PLStryker CorporationOVD2015-09-14
07613153046349AVS PLStryker CorporationOVD2015-09-14
07613153046356AVS PLStryker CorporationOVD2015-09-14
07613153046363AVS PLStryker CorporationOVD2015-09-14
07613153046370AVS PLStryker CorporationOVD2015-09-14